Lumbar Spinal StenosisNCT07001982
Lumbar Spinal Stenosis and Central Sensitization
An observational study of Lumbar Spinal Stenosis, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
Lumbar spinal stenosis (LSS) functionally limits individuals by causing pain in both the waist and the legs during activity and walking. Pain is, therefore, an important problem for patients. Pain lasts for years in LSS and thus becomes chronically persistent. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Lumbar Spinal Stenosis
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jun 2025to 15 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients with lumbar spinal stenosis will be included in this study.
Who may be able to join
- Diagnosed with lumbar spinal stenosis by MRI,
- The ages of 45-80,
- Low back and/or leg pain that has persisted for at least 3 months
- Volunteer to participate in the study
Who cannot join
- Patients who did not agree to participate in the study,
- Those with a history of serious neurological diseases such as Parkinson's, hemiplegia, multiple sclerosis,
- Those who had undergone surgery in the lumbar region within the last year,
- Those with advanced joint disease in the lower extremity,
- Those with malignancy in the spine,
- Those who had a previous operation for the lower extremity,
Show all 10Show fewer
- Those who had a pain or disability in other musculoskeletal joints,
- Those who had a psychological disorder or peripheral vascular disease
- Those who had any concurrent serious medical condition, including sepsis or cancer
- Those who did not cooperate well were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Central Sensitization, Pain and Depression Patients With Lumbar Spinal Stenosis
Lumbar spinal stenosis (LSS) functionally limits individuals by causing pain in both the waist and the legs during activity and walking. Pain is, therefore, an important problem for patients. Pain lasts for years in LSS and thus becomes chronically persistent. As a result, persistent pain can cause sensitization due to a decrease in the pain threshold. This condition affects patients not only biomedically but also biopsychosocially. For this reason, various sleep disorders and mood disorders can develop in patients. Therefore, this study aimed to examine the relationship between central sensitization and pain, disability, sleep and depression in patients with LSS.
Read the detailed description
Lumbar spinal stenosis (LSS) functionally limits individuals by causing pain in both the waist and the legs during activity and walking. In particular, the pain in LSS lasts for years and becomes chronic and can cause persistent and disturbing sensitization. This situation may be associated with decreased pain threshold and allodynia. Various studies show that sensitization can affect individuals biomedically and may lead to important health problems. Some of these are sleep and depression problems. Sleep and a healthy mentality are important for continuing daily activities and preserving quality of life. However, when the literature is examined, it is seen that central sensitization and the parameters that may be related to this have not been examined sufficiently. Therefore, the aim of this study is to examine the relationship between central sensitization and pain, disability, sleep and depression in patients with LSS.
- Conditions
- Lumbar Spinal Stenosis
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with central sensitization with LSS | Patients with lumbar spinal stenosis with high sensitization will be included. | |
| Normal sensitization patients with LSS | Patients with lumbar spinal stenosis with normal sensitization will be included. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central sensitization
Central sensitization will be assessed with the "Central Sensitization Scale". The total score range is between 0-100 points. As the score increases, sensitization increases and 40 points and above are considered higher sensitization.
Measured: Baseline
Pain severity
Pain intensity will be assessed with Numeric Rating Scale (NRS). NRS varies between 0-10 and the higher the score, the greater the pain.
Measured: Baseline
Pain pressure threshold
Pressure pain threshold will be measured with an algometer in kg. High values indicate a high pain threshold.
Measured: Baseline
Disability levels
Disability will be measured by the Oswestry Disability Index. The total score ranges from 0-100 and the higher the score, the higher the level of disability.
Measured: Baseline
Pain catastrophizing
It will be evaluated using the pain catastrophizing scale. The total score varies between 0-52. As the score increases, negative feelings and thoughts increase.
Measured: Baseline
Sleep quality
Sleep quality will be assessed with the Pittsburgh Sleep Quality Index. It is scored from 0 to 21, with higher scores indicating worse sleep quality.
Measured: Baseline
Depression
The Center for Epidemiological Studies Depression Scale (CES-D) will be used to assess depression.The total score is 0-60. As the score increases, depression increases.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start17 Jun 2025
- Primary completion15 Oct 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Musa Güneş, Karabuk University
- Investigators
- Musa Güneş, PhD, Study director, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07001982
- Sponsor's protocol ID
- Karabuk-2325
- Status last verified
- Apr 2026
- First submitted
- 23 May 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Iwasaki R, Miki T, Miyazaki M, Kanetaka C, Mitsuyama T, Ota K. Neuropathic Pain Was Associated with Central Sensitivity Syndrome in Patients with Preoperative Lumbar Spinal Stenosis Using the painDETECT and Central Sensitization Inventory Questionnaires: A Cross-Sectional Study. Pain Res Manag. 2023 May 10;2023:9963627. doi: 10.1155/2023/9963627. eCollection 2023.
PubMed 37207128Ogon I, Takashima H, Morita T, Fukushi R, Takebayashi T, Teramoto A. Association of central sensitization, visceral fat, and surgical outcomes in lumbar spinal stenosis. J Orthop Surg Res. 2023 Nov 21;18(1):886. doi: 10.1186/s13018-023-04376-2.
PubMed 37990264
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Central Sensitization, Pain and Depression Patients With Lumbar Spinal Stenosis
- ClinicalTrials.gov ID
- NCT07001982
- Acronym / sponsor ID
- Karabuk-2325
- Conditions
- Lumbar Spinal Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 3 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lumbar spinal stenosis (LSS) functionally limits individuals by causing pain in both the waist and the legs during activity and walking. Pain is, therefore, an important problem for patients. Pain lasts for years in LSS and thus becomes chronically persistent. As a result, persistent pain can cause sensitization due to a decrease in the pain threshold. This condition affects patients not only biomedically but also biopsychosocially. For this reason, various sleep disorders and mood disorders can develop in patients. Therefore, this study aimed to examine the relationship between central sensitization and pain, disability, sleep and depression in patients with LSS.
Detailed description
Lumbar spinal stenosis (LSS) functionally limits individuals by causing pain in both the waist and the legs during activity and walking. In particular, the pain in LSS lasts for years and becomes chronic and can cause persistent and disturbing sensitization. This situation may be associated with decreased pain threshold and allodynia. Various studies show that sensitization can affect individuals biomedically and may lead to important health problems. Some of these are sleep and depression problems. Sleep and a healthy mentality are important for continuing daily activities and preserving quality of life. However, when the literature is examined, it is seen that central sensitization and the parameters that may be related to this have not been examined sufficiently. Therefore, the aim of this study is to examine the relationship between central sensitization and pain, disability, sleep and depression in patients with LSS.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with central sensitization with LSS | – | –Patients with lumbar spinal stenosis with high sensitization will be included. |
| Normal sensitization patients with LSS | – | –Patients with lumbar spinal stenosis with normal sensitization will be included. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with lumbar spinal stenosis will be included in this study.
Key inclusion criteria (4 listed)
- Diagnosed with lumbar spinal stenosis by MRI,
- The ages of 45-80,
- Low back and/or leg pain that has persisted for at least 3 months
- Volunteer to participate in the study
Key exclusion criteria (10 listed)
- Patients who did not agree to participate in the study,
- Those with a history of serious neurological diseases such as Parkinson's, hemiplegia, multiple sclerosis,
- Those who had undergone surgery in the lumbar region within the last year,
- Those with advanced joint disease in the lower extremity,
- Those with malignancy in the spine,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Central sensitization
Time frame: Baseline
Central sensitization will be assessed with the "Central Sensitization Scale". The total score range is between 0-100 points. As the score increases, sensitization increases and 40 points and above are considered higher sensitization.
Pain severity
Time frame: Baseline
Pain intensity will be assessed with Numeric Rating Scale (NRS). NRS varies between 0-10 and the higher the score, the greater the pain.
Pain pressure threshold
Time frame: Baseline
Pressure pain threshold will be measured with an algometer in kg. High values indicate a high pain threshold.
Disability levels
Time frame: Baseline
Disability will be measured by the Oswestry Disability Index. The total score ranges from 0-100 and the higher the score, the higher the level of disability.
Pain catastrophizing
Time frame: Baseline
It will be evaluated using the pain catastrophizing scale. The total score varies between 0-52. As the score increases, negative feelings and thoughts increase.
Sleep quality
Time frame: Baseline
Sleep quality will be assessed with the Pittsburgh Sleep Quality Index. It is scored from 0 to 21, with higher scores indicating worse sleep quality.
Depression
Time frame: Baseline
The Center for Epidemiological Studies Depression Scale (CES-D) will be used to assess depression.The total score is 0-60. As the score increases, depression increases.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Results publication: PubMed 37207128Iwasaki R, Miki T, Miyazaki M, Kanetaka C, Mitsuyama T, Ota K. Neuropathic Pain Was Associated with Central Sensitivity Syndrome in Patients with Preoperative Lumbar Spinal Stenosis Using the painDETECT and Central Sensitization Inventory Questionnaires: A Cross-Sectional Study. Pain Res Manag. 2023 May 10;2023:9963627. doi: 10.1155/2023/9963627. eCollection 2023.
- Results publication: PubMed 37990264Ogon I, Takashima H, Morita T, Fukushi R, Takebayashi T, Teramoto A. Association of central sensitization, visceral fat, and surgical outcomes in lumbar spinal stenosis. J Orthop Surg Res. 2023 Nov 21;18(1):886. doi: 10.1186/s13018-023-04376-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Musa Güneş, PhD study director
Karabuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spinal Stenosis, run by Karabuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central sensitization (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07001982, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.